Fatty acids, coco, esters with 3,3'-oxybis[1,2-propanediol]

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, coco, esters with 3,3'-oxybis[1,2-propanediol]

EC Number:

285-089-6

EC Name:

Fatty acids, coco, esters with 3,3'-oxybis[1,2-propanediol]

Cas Number:

85029-63-6

Molecular formula:

not applicable, mixture

IUPAC Name:

Fatty acids, coco, esters with 3,3'-oxybis[1,2-propanediol]

Test material form:

liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Origin: HOECHST AG, Kastengrund, conventional breed
Body weights: 3.4 - 3.9 kg
Age: approx. 3-5 months

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.5 ml of pure substance

Duration of treatment / exposure:

4 hours

Observation period:

The animals were assessed at 30 min, 60 min, 24 h, 48 h and 72 h after exposure.

Number of animals:

3

Details on study design:

Approximately 24 h before test start, the three test animals were clipped in an area of 25 cm² in the dorsal region with an electric clipper. Only animals with intact skin were used for the test. Each animal was treated with 0.5 ml pure test substance on the prepared skin area which was then covered with a 2.5 x 2.5 cm gauze patch then. The test site was then covered with a semi-occlusive dressing. The exposure time was 4 hours. After exposure, the patch was removed and the treated area washed with lukewarm water to remove the test substance from the skin. The treated skin was examined 30 min, 60 min, 24 h, 48 h and 72 h after removal of the patch for erythema, oedema or incrustation of the skin and scored, respectively.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.3

Max. score:

0.3

Reversibility:

fully reversible

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Irritant / corrosive response data:

Very slight erythema and oedema were observed 1 and 24 h after removal of the patch. However, these observations were reversible 48 h after removal of the patch.

Applicant's summary and conclusion

Interpretation of results:

other: not irritant to skin

Conclusions:

The test substance is not irritating to skin.

Executive summary:

The skin irritation / corrosion properties of the test substance was assessed in an in vivo skin irritation study with rabbits. As a result of the study, the test substance is not irritating to skin.